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Trial record 19 of 50 for:    alzheimer's OR alzheimer's disease | Open Studies | NIH
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Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease

This study is currently recruiting participants.
Verified December 2012 by Seattle Institute for Biomedical and Clinical Research
Sponsor:
Collaborators:
National Institute on Aging (NIA)
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT01126099
First received: May 17, 2010
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

A study of outpatient participants with Alzheimer's disease or a related dementia who have difficult behaviors that are upsetting for them or their caregivers. Prazosin is a medication that is commonly used to treat people with high blood pressure. Research with prazosin has shown that it may be effective in treating behavioral problems by reducing excess adrenalin effects in the brain.


Condition Intervention
Alzheimer's Disease
 Drug: Prazosin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change & Neuropsychiatric Inventory total score [ Time Frame: 12 Weeks after Baseline ] [ Designated as safety issue: No ]
    Scores from baseline to last observation


Secondary Outcome Measures:
  • Number of study days completed & Brief Psychiatric Rating Scale total score [ Time Frame: 12 Weeks after Baseline ] [ Designated as safety issue: No ]
    Brief Psychiatric Rating Scale score change from Baseline to last observation


Estimated Enrollment: 120
Study Start Date: March 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prazosin
In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
 Drug: Prazosin
4 mg capsules twice daily for 12 weeks
Other Name: minipress
Placebo Comparator: Placebo
In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
 Drug: Placebo
Placebo capsules twice daily for 12 weeks
Other Name: inert substance

Detailed Description:

This is a 24 week study with 14 visits to the research clinic. Approximately 6 of these visits may be done by phone. Additional phone checks are scheduled at the beginning of each 12 week part of the study. Participants will have a 50:50 chance of being on prazosin or placebo in the first 12 weeks of the study. For the second 12 weeks, all participants will take prazosin.

Study visits include a physical and neurological exam; memory testing; interviews with the caregiver about behaviors; and vital signs.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No age limit
  • Probable or Possible Alzheimer's Disease
  • Disruptive agitated behaviors at least twice a week (overly anxious or excited, making offensive comments.....)
  • Stable medications for 2 weeks
  • Must have a caregiver who spends 10 hours per week caring for the participant and agrees to participate in all evaluation sessions

Exclusion Criteria:

  • Cardiovascular: unstable angina, recent myocardial infarction, preexisting hypotension (systolic BP less than 110) or orthostatic hypotension (≥20 mmHg drop in systolic BP following 2 minutes of standing posture)
  • Any unstable medical condition
  • Exclusionary medications: current treatment with prazosin, other alpha-1 blockers (trazodone, sildenafil, vardenafil or tadalafil)
  • Psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. Partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. Although not formally rated, this improvement is equivalent to a Clinical Global Impression of Change rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient).
  • Psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126099

Contacts
Contact: Lucy Wang, MD (206) 277-5089 wanglucy@u.washington.edu
Contact: Kirsten Rohde, RN (206) 764-2713 kirsten.rohde@va.gov

Locations
United States, Washington
Veterans Affairs Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Lucy Wang, MD     206-277-5089     wanglucy@u.washington.edu    
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
National Institute on Aging (NIA)
VA Puget Sound Health Care System
Investigators
Principal Investigator: Elaine R Peskind, MD University of Washington, VA Puget Sound Health Care System
  More Information

No publications provided

Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT01126099     History of Changes
Other Study ID Numbers: 1RO1AG033133-01A1
Study First Received: May 17, 2010
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
double-blind
treatment
prazosin
Disruptive behaviors in Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Tauopathies
Prazosin
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013